[Hiring] Compliance Specialist, Audits and Inspections, Client Audits @Thermo Fisher Scientific

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a Compliance Specialist, you will execute quality and compliance processes across the organization. Your responsibilities will include: • Facilitating the tracking and reporting of quality and compliance activities • Maintaining tools and materials and providing expertise to advance the vision of the department • Investigating and resolving issues, monitoring metrics, and maintaining reports and documentation associated with quality and compliance activities • Managing quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish • Coordinating smaller projects and process/quality improvement initiatives with proven results • Communicating with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents) • Mentoring staff and serving as a team lead for group projects or process improvement initiatives Qualifications • Bachelor's degree in a related field or equivalent formal academic/vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • Experience with clinical project coordination, clinical project administrator or similar experience is required • Able to go onsite to the Austin, Texas office 1-3 times per month, so must be within drivable distance to Austin, Texas • Client facing experience is preferred Requirements • Excellent oral and written communication skills • Strong organizational and time-management skills • Firm knowledge of the clinical trial process • Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines • Effective problem solving skills • Strong attention to detail • Ability to work independently as required • Strong computer skills; ability to learn and become proficient with appropriate software • Ability to multitask and prioritize competing demands/work load • Demonstrated flexibility and adaptability Benefits • Fully remote in the US. Relocation assistance is NOT provided • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, which includes a drug screening Apply Now Apply Now